Useful information

The process of making medicine

2018/08/01

When reading “medicine” (Kusuri) in reverse (ri-su-ku), it reads as “risk”. Medicine has risks.
However, in order to reduce the risks as much as possible so that one can take it safely, it undergoes a number of “trials” before the medication can be manufactured.
It will take at least ten years for a medication to be created.
First, it begins with seeking a “substance that is the source of the medication”, but it’s said that,
beginning with the idea that “it will be a potential medication,” the actual probability that the compound that started the study will appear as a new drug is 1 in 20,000. There is a great deal of trial and error.
Once potential drugs are found, research will be conducted on animals and artificially cultured cells to confirm efficacy and safety (= non-clinical studies).

The clinical trial is the third stage

After clearing the non-clinical study, we will finally test for effectiveness and safety for human beings. This is a “clinical trial”, a so-called analysis.
This clinical trial has three steps.
The first step (Phase I study) is targeted to a small number of healthy adults. A small amount is administered to see how the medicine is absorbed and excreted by the body.
(Depending on the type of medicine, such as anti-cancer drugs, we will begin targeting patients.)
In the second step (Phase II study), we examine multiple doses, dosing periods, and dosing intervals for a small group of patients and consider appropriate usage while looking at both effects and side effects .
In the third step (Phase III study), we will confirm the effectiveness and safety for many patients compared with existing drugs and placebos (placebo). Here, compared to existing medicine, the effect should be better, side effects should be less, and good results should be obtained.

There is “review” even after release as a medication

After completing the non-clinical trial and the three clinical trials (clinical trial), the results are submitted collectively to the Ministry of Health, Labor and Welfare, and are evaluated by experts. And, if validity and safety are confirmed, it will be approved, and it will be defined as “medication”.
When it is released as a medication, it will be used by many patients during routine medical treatment, but confirmation of efficacy and safety is not over.
Actually, “review after manufacturing and sales” will be continued to confirm effectiveness and safety in daily practice. In addition, in Japan, a “reexamination system” has been established to collect data from actual clinical sites and review the efficacy, effectiveness and safety again after a certain period of time (in the case of many new drugs, 8 years) has elapsed.
As you can see, medications currently in use have passed through many reviews, and are still existent now.